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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031779
Receipt No. R000036265
Scientific Title attempt to develop a new family-assessment by means of realtime biological indices
Date of disclosure of the study information 2018/03/18
Last modified on 2018/03/18

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Basic information
Public title attempt to develop a new family-assessment by means of realtime biological indices
Acronym a family-assessment by biological indices
Scientific Title attempt to develop a new family-assessment by means of realtime biological indices
Scientific Title:Acronym a family-assessment by biological indices
Region
Japan

Condition
Condition social anxiety disorder, adjustment disorder, eating disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects of realtime biological indices for family-assessment at the begining of family therapy for mental disorders
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes some psychological examinations (e.g. Family Assessment Device Profile of Mood States)
directly before family therapy and six months after the begining of family therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Seven family therapy sessions of 60 minites will be conducted every 2 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
8 years-old <=
Age-upper limit
30 years-old >
Gender Male and Female
Key inclusion criteria patients who are diagnosed as social anxiety disorder, adjustment disorder or eating disorder by DMS-5 and recommended family therapy by their psychiatrists in charge, and whose both parents can attend each session of family therapy
Key exclusion criteria Exclusion criteria are not established.
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoko MURAMATSU
Organization Kyoto Notre Dame University
Division name Department of Psychology
Zip code
Address 1, Shimogamo-Minaminonogamicho, Sakyo-ku, Kyoto
TEL 075-706-3680
Email Muratomo@notredame.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko MURAMATSU
Organization Kyoto Notre Dame University
Division name Department of Psychology
Zip code
Address 1, Shimogamo-Minaminonogamicho, Sakyo-ku, Kyoto
TEL 075-706-3680
Homepage URL
Email Muratomo@notredame.ac.jp

Sponsor
Institute Department of Psychology, Kyoto Notre Dame University
Institute
Department

Funding Source
Organization the Ministry of Education, Culture, Sports, Science and Technology

Kyoto Notre Dame University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Grants-in-Aid for Scientific Research

Other related organizations
Co-sponsor Iwakura Hospital
Name of secondary funder(s) Kyoto University

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 18 Day
Last modified on
2018 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036265

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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